DiabetesNCT03987438
A Behavioral Intervention to Prevent Impaired Glucose Tolerance Diabetes Mellitus (DIGITAL-I)
A study testing Lifestyle intervention with APP in people with Diabetes, run by Peking University Third Hospital at 1 site in China.
Trial summary
The national epidemiological survey showed that the prevalence rate of pre-diabetes was up to 35.7% in China. Previous study indicated that lifestyle intervention in people with impaired glucose tolerance could delay the onset of type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Lifestyle intervention with APP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,336 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years old
- Impaired glucose tolerance will be diagnosed by a 75g OGTT according to the criteria of World Health Organization as a fasting plasma glucose level between 6.1 mmol/L and 7.0 mmol/L, or 2-hour value between 7.8 mmol/L and 11.1 mmol/L
- Willing to keep reading the education articles and supporting materials that delivered by the mobile APP
- Willing to provide informed consent
Who cannot join
- Pregnant women, pregnant or lactating women (Can be reassessed after childbirth or after breastfeeding)
- Inconvenient to move, far away from the center to limit follow-up, more than 2 hours drive from the center
- Cannot complete the test because of planning migration
- Schizophrenia, manic depression, drug or alcohol addicts
- Cancer patients who have been treated in the past 5 years
- HIV positive (report)
Show all 14Show fewer
- Active tuberculosis
- Patients with severe CVD (Myocardial infarction, heart failure, stroke) or pulmonary embolism in the past 6 months
- Unstable angina or resting angina; history of cardiac arrest; severe arrhythmia; uncontrolled atrial fibrillation (heart rate not less than 100 beats / min); cardiac function by New York Cardiology Society Grade III ~ IV; acute myocarditis, pericarditis or hypertrophic cardiomyopathy; clinically significant aortic stenosis; severe left bundle branch block or installation of a pacemaker (unless agreed by a cardiologist); history of defibrillation; aortic aneurysm diameter > 7cm or history of aortic rupture; history of heart transplantation; resting heart rate <45 beats / min or > 100 beats / min
- Cirrhosis; Cushing's syndrome; acromegaly; long-term application of glucocorticoids
- Serum creatinine is 2 times higher than the upper limit of normal; currently undergoing dialysis
- Chronic anoxia diseases such as emphysema, pulmonary heart disease, etc.
- Rheumatic heart disease; congenital heart disease
- Organ transplantation patients
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital YanQing Hospital
Beijing, Beijing Municipality
Jinzhan Song, MS, +8615811096083, guliangbiao@163.com
About this study
Official title: Diabetes Mellitus, Impaired Glucose Tolerance and Gestational Diabetes Mellitus Intervention Action-Leading Trial- Impaired Glucose Tolerance Study (DIGITAL-I Study)
The national epidemiological survey showed that the prevalence rate of pre-diabetes was up to 35.7% in China. Previous study indicated that lifestyle intervention in people with impaired glucose tolerance could delay the onset of type 2 diabetes. However, patients with pre-diabetes do not pay enough attention to their glucose metabolism, and most of them rarely monitor their blood glucose. With the increasing use of smartphones, mobile applications (APPs) can be applied in the education and management of chronic diseases, including diabetes. Thus, the investigators will conduct a multi-centered, two-armed, open-labeled, randomized controlled trial to evaluate whether the behavioral intervention by a mobile APP can prevent the occurrence of diabetes in people with impaired glucose tolerance.
The investigators hypothesize that behavioral intervention in pre-diabetes with using a mobile APP that incorporates nutrition, exercise and psychological support from trained professional doctors will:
- Reduce the risk of the onset of diabetes in people with impaired glucose tolerance.
- Increase the reversal rate of becoming normal glucose tolerance and reduce the levels of glycosylated hemoglobin in pre-diabetes.
Read the detailed description
Participants from fourteen research centers in the mainland of China will be recruited in the study. People will be screened for a 75g oral glucose tolerance test (OGTT). The patients whose fasting glucose between 6.1mmol/L and 7.0mmol/L or 2-hour value between 7.8mmol/L and 11.1mmol/L will be diagnosed with impaired glucose tolerance and recommended to participate in the study.
People who meet the eligibility criteria and who are willing to provide informed consent will be enrolled and randomized to behavioral intervention group and control group. People in the behavioral intervention group will be educated and monitored by a mobile APP that provides behavioral support including health knowledge education, mental health counseling, smart diet advice, intelligent exercise guidance, and target weight management. Meanwhile, the behavioral support will be modified by endocrinologists, dieticians, sports medicine professionals and psychologists individually based on the feedback of their characteristics and performance recorded in the APP. Participants randomized to the control group only have regular care in their local hospitals.
Every three months, participants in the intervention group will be back to their research centers and be collected with information including HbA1c levels, blood pressure, heart rate tests, adverse events, combined medications and health checklists. Investigators conduct face-to-face health education, lifestyle guidance and mobile APP software inspection. Every one year, 75g OGTT (0min, 60min, 120min points of blood glucose and insulin levels), liver and kidney function, blood lipids, glycosylated hemoglobin, urine routine and electrocardiogram will be evaluated in both of the group. Investigators will compare the diabetes risk in the two groups to evaluate whether behavioral intervention with a mobile APP can reduce the risk of the onset of diabetes in people with impaired glucose tolerance. Investigators also will compare the reversal rate of becoming normal glucose tolerance in prediabetes and the changes of glycosylated hemoglobin levels in both groups. Behavioral intervention with the APP will last for two years.
- Conditions
- Diabetes
- Being tested
- Lifestyle intervention with APP
- Keywords
- Behavioral intervention, Imparied glucose tolerance, Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle intervention with APPBehavioural
The lifestyle intervention will be launched by an APP installed in participants' private mobile phones, including health knowledge education, mental health counseling, smart diet advice, intelligent exercise guidance, and target weight management. Nutrition recommendation is conducted according to the Chinese Dietary Guide, Chinese and International Guidelines of Gestation Diabetes Management. Exercise guidance is given based on the Guidelines for National Fitness of China, Chinese and International Guidelines of Gestation Diabetes Management. Psychological support is given by sending education articles on mental health. Participants are encouraged to update data about their diet, exercise and body weight through the APP. The face to face education class will be conducted by an obstetrician, an endocrinologist and a nutritionist together to modify the behavioral supports individually based on the feedback of their characteristics and performance recorded in the APP.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral intervention | Experimental | Participants randomized to the behavioral intervention group will be provided with a mobile APP which incorporates behavioral support including health knowledge education, mental health counseling, diet advice, exercise guidance and weight management. Meanwhile, the behavioral support will be modified by endocrinologists, dieticians, sports medicine professionals and psychologists individually based on the feedback of their performance recorded in the APP. Every three months, participants in the intervention group will be back to their research centers and be collected with information including HbA1c levels, blood pressure, heart rate tests and adverse events. Investigators conduct face-to-face health education, lifestyle guidance, mobile APP software inspection. Every one year, 75g OGTT (0min,60min, 120min points of blood glucose and insulin levels), liver and kidney function, blood lipids, glycosylated hemoglobin, urine routine and electrocardiogram will be evaluated. Receives: Behavioral: Lifestyle intervention with APP |
| Control group | No intervention | Participants randomized to the control group have regular care in their local hospitals. Every three months, participants in the intervention group will be back to their research centers and be collected with information including HbA1c levels, blood pressure, heart rate tests and adverse events. Every one year, 75g OGTT (0min,60min, 120min points of blood glucose and insulin levels), liver and kidney function, blood lipids, glycosylated hemoglobin, urine routine and electrocardiogram will be evaluated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The risk of diabetes mellitus (DM) in patients with impaired glucose tolerance
DM will be diagnosed by a 75g OGTT according to the World Health Organization criteria as fasting plasma glucose level 7.0 mmol/L or more, or 2-hour value 11.1 mmol/L or more. Investigators will compare the diabetes risk in the two groups to evaluate whether behavioral intervention with a mobile APP can reduce the risk of the onset of diabetes in people with impaired glucose tolerance.
Measured: 2 years
Secondary outcomes (2)
Reversal rate of becoming normal glucose tolerance in pre-diabetes
Every one year, 75g OGTT (0min,60min, 120min points of blood glucose and insulin levels) will be evaluated in both of the group. Investigators will compare the reversal rate of becoming normal glucose tolerance in pre-diabetes.
Measured: 2 years
Changes in glycosylated hemoglobin levels.
Glycosylated hemoglobin levels will be recorded at the beginning, middle and end of the study. Investigators will compare the changes in glycosylated hemoglobin levels.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start3 Aug 2019
- Primary completion30 Nov 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tianpei Hong, MD,PhD, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987438
- Sponsor's protocol ID
- DIGITAL-I-2019
- Status last verified
- Apr 2019
- First submitted
- 12 Jun 2019
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Mellitus, Impaired Glucose Tolerance and Gestational Diabetes Mellitus Intervention Action-Leading Trial- Impaired Glucose Tolerance Study (DIGITAL-I Study)
- ClinicalTrials.gov ID
- NCT03987438
- Acronym / sponsor ID
- DIGITAL-I-2019
- Conditions
- Diabetes
- Keywords
- Behavioral intervention, Imparied glucose tolerance, Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,336 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 3 Aug 2019 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 17 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The national epidemiological survey showed that the prevalence rate of pre-diabetes was up to 35.7% in China. Previous study indicated that lifestyle intervention in people with impaired glucose tolerance could delay the onset of type 2 diabetes. However, patients with pre-diabetes do not pay enough attention to their glucose metabolism, and most of them rarely monitor their blood glucose. With the increasing use of smartphones, mobile applications (APPs) can be applied in the education and management of chronic diseases, including diabetes. Thus, the investigators will conduct a multi-centered, two-armed, open-labeled, randomized controlled trial to evaluate whether the behavioral intervention by a mobile APP can prevent the occurrence of diabetes in people with impaired glucose tolerance.
The investigators hypothesize that behavioral intervention in pre-diabetes with using a mobile APP that incorporates nutrition, exercise and psychological support from trained professional doctors will:
- Reduce the risk of the onset of diabetes in people with impaired glucose tolerance.
- Increase the reversal rate of becoming normal glucose tolerance and reduce the levels of glycosylated hemoglobin in pre-diabetes.
Detailed description
Participants from fourteen research centers in the mainland of China will be recruited in the study. People will be screened for a 75g oral glucose tolerance test (OGTT). The patients whose fasting glucose between 6.1mmol/L and 7.0mmol/L or 2-hour value between 7.8mmol/L and 11.1mmol/L will be diagnosed with impaired glucose tolerance and recommended to participate in the study.
People who meet the eligibility criteria and who are willing to provide informed consent will be enrolled and randomized to behavioral intervention group and control group. People in the behavioral intervention group will be educated and monitored by a mobile APP that provides behavioral support including health knowledge education, mental health counseling, smart diet advice, intelligent exercise guidance, and target weight management. Meanwhile, the behavioral support will be modified by endocrinologists, dieticians, sports medicine professionals and psychologists individually based on the feedback of their characteristics and performance recorded in the APP. Participants randomized to the control group only have regular care in their local hospitals.
Every three months, participants in the intervention group will be back to their research centers and be collected with information including HbA1c levels, blood pressure, heart rate tests, adverse events, combined medications and health checklists. Investigators conduct face-to-face health education, lifestyle guidance and mobile APP software inspection. Every one year, 75g OGTT (0min, 60min, 120min points of blood glucose and insulin levels), liver and kidney function, blood lipids, glycosylated hemoglobin, urine routine and electrocardiogram will be evaluated in both of the group. Investigators will compare the diabetes risk in the two groups to evaluate whether behavioral intervention with a mobile APP can reduce the risk of the onset of diabetes in people with impaired glucose tolerance. Investigators also will compare the reversal rate of becoming normal glucose tolerance in prediabetes and the changes of glycosylated hemoglobin levels in both groups. Behavioral intervention with the APP will last for two years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral intervention | Experimental | Behavioral: Lifestyle intervention with APPParticipants randomized to the behavioral intervention group will be provided with a mobile APP which incorporates behavioral support including health knowledge education, mental health counseling, diet advice, exercise guidance and weight management. Meanwhile, the behavioral support will be modified by endocrinologists, dieticians, sports medicine professionals and psychologists individually based on the feedback of their performance recorded in the APP. Every three months, participants in the intervention group will be back to their research centers and be collected with information including HbA1c levels, blood pressure, heart rate tests and adverse events. Investigators conduct face-to-face health education, lifestyle guidance, mobile APP software inspection. Every one year, 75g OGTT (0min,60min, 120min points of blood glucose and insulin levels), liver and kidney function, blood lipids, glycosylated hemoglobin, urine routine and electrocardiogram will be evaluated. |
| Control group | No intervention | –Participants randomized to the control group have regular care in their local hospitals. Every three months, participants in the intervention group will be back to their research centers and be collected with information including HbA1c levels, blood pressure, heart rate tests and adverse events. Every one year, 75g OGTT (0min,60min, 120min points of blood glucose and insulin levels), liver and kidney function, blood lipids, glycosylated hemoglobin, urine routine and electrocardiogram will be evaluated. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 70 years old
- Impaired glucose tolerance will be diagnosed by a 75g OGTT according to the criteria of World Health Organization as a fasting plasma glucose level between 6.1 mmol/L and 7.0 mmol/L, or 2-hour value between 7.8 mmol/L and 11.1 mmol/L
- Willing to keep reading the education articles and supporting materials that delivered by the mobile APP
- Willing to provide informed consent
Key exclusion criteria (14 listed)
- Pregnant women, pregnant or lactating women (Can be reassessed after childbirth or after breastfeeding)
- Inconvenient to move, far away from the center to limit follow-up, more than 2 hours drive from the center
- Cannot complete the test because of planning migration
- Schizophrenia, manic depression, drug or alcohol addicts
- Cancer patients who have been treated in the past 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle intervention with APPThe lifestyle intervention will be launched by an APP installed in participants' private mobile phones, including health knowledge education, mental health counseling, smart diet advice, intelligent exercise guidance, and target weight management. Nutrition recommendation is conducted according to the Chinese Dietary Guide, Chinese and International Guidelines of Gestation Diabetes Management. Exercise guidance is given based on the Guidelines for National Fitness of China, Chinese and International Guidelines of Gestation Diabetes Management. Psychological support is given by sending education articles on mental health. Participants are encouraged to update data about their diet, exercise and body weight through the APP. The face to face education class will be conducted by an obstetrician, an endocrinologist and a nutritionist together to modify the behavioral supports individually based on the feedback of their characteristics and performance recorded in the APP. | Behavioural | Behavioral intervention |
Primary outcome
The risk of diabetes mellitus (DM) in patients with impaired glucose tolerance
Time frame: 2 years
DM will be diagnosed by a 75g OGTT according to the World Health Organization criteria as fasting plasma glucose level 7.0 mmol/L or more, or 2-hour value 11.1 mmol/L or more. Investigators will compare the diabetes risk in the two groups to evaluate whether behavioral intervention with a mobile APP can reduce the risk of the onset of diabetes in people with impaired glucose tolerance.
2 secondary outcomes
Reversal rate of becoming normal glucose tolerance in pre-diabetes
Time frame: 2 years
Changes in glycosylated hemoglobin levels.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tianpei Hong, MD,PhD principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention with APP in people with Diabetes, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tianpei Hong, MD,PhD (+8613683265725 ext. +8615611908212, tpho66@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The risk of diabetes mellitus (DM) in patients with impaired glucose tolerance (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019; AzTrials last refreshed its copy on 8 Nov 2026.